Sphincter treatment apparatus

ABSTRACT

A sphincter treatment apparatus includes an energy delivery device introduction member including a plurality of arms. Each arm has distal and proximal sections. The distal sections of the arms are coupled as are the proximal sections of the arms. The energy delivery device introduction member is configured to be introduced in the sphincter in a non-deployed state, expand to a deployed state to at least partially expand the sphincter. A plurality of energy delivery devices are coupled to the energy delivery device introduction member. At least a portion of the plurality of energy delivery devices are controllably introducible from the energy delivery device introduction member into the sphincter.

CROSS-RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 09/026,316 filed Feb. 19, 1998, which is acontinuation-in-part of U.S. patent application Ser. No. 08/731,372,filed Oct. 11, 1996, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/319,373, filed Oct. 6, 1994, which is acontinuation-in-part of U.S. application Ser. No. 08/286,862, filed Aug.4, 1994, which is a continuation-in-part of U.S. patent application Ser.No. 08/272,162, filed Jul. 7, 1994, which is a continuation-in-part ofU.S. patent application Ser. No. 08/265,459, filed Jun. 24, 1994, and isrelated to concurrently filed Application entitled “GERD TreatmentApparatus and Method” identified as Attorney Docket 14800-748, all withnamed inventor Stuart D. Edwards, and all of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates generally to an apparatus for thetreatment of sphincters, and more specifically to an apparatus thattreats esophageal sphincters.

[0004] 2. Description of Related Art

[0005] Gastroesophageal reflux disease (GERD) is a commongastroesophageal disorder in which the stomach contents are ejected intothe lower esophagus due to a dysfunction of the lower esophagealsphincter (LES). These contents are highly acidic and potentiallyinjurious to the esophagus resulting in a number of possiblecomplications of varying medical severity. The reported incidence ofGERD in the U.S. is as high as 10% of the population (Castell D O;Johnston B T: Gastroesophageal Reflux Disease: Current Strategies ForPatient Management. Arch Fain Med, 5(4):221-7; (1996 April)).

[0006] Acute symptoms of GERD include heartburn, pulmonary disorders andchest pain. On a chronic basis, GERD subjects the esophagus to ulcerformation, or esophagitis and may result in more severe complicationsincluding esophageal obstruction, significant blood loss and perforationof the esophagus. Severe esophageal ulcerations occur in 20-30% ofpatients over age 65. Moreover, GERD causes adenocarcinoma, or cancer ofthe esophagus, which is increasing in incidence faster than any othercancer (Reynolds J C: Influence Of Pathophysiology, Severity, And CostOn The Medical Management Of Gastroesophageal Reflux Disease. Am JHealth Syst Pharm, 53(22 Suppl 3):S5-12 (1996 Nov 15)).

[0007] One of the possible causes of GERD may be aberrant electricalsignals in the LES or cardia of the stomach. Such signals may cause ahigher than normal frequency of relaxations of the LES allowing acidicstomach contents to be repeatedly ejected into the esophagus and causethe complications described above. Research has shown that unnaturalelectrical signals in the stomach and intestine can cause reflux eventsin those organs (Kelly K A, et al: Duodenal-gastric Reflux and SlowedGastric Emptying by Electrical Pacing of the Canine Duodenal PacesetterPotential. Gastroenterology. 1977 Mar; 72(3): 429-433). In particular,medical research has found that sites of aberrant electrical activity orelectrical foci may be responsible for those signals (Karlstrom L H, etal.: Ectopic Jejunal Pacemakers and Enterogastric Reflux after RouxGastrectomy: Effect Intestinal Pacing. Surgery. 1989 Sep; 106(3):486-495). Similar aberrant electrical sites in the heart which causecontractions of the heart muscle to take on life threatening patterns ordysrhythmias can be identified and treated using mapping and ablationdevices as described in U.S. Pat. No. 5,509,419. However, there is nocurrent device or associated medical procedure available for theelectrical mapping and treatment of aberrant electrical sites in the LESand stomach as a means for treating GERD.

[0008] Current drug therapy for GERD includes histamine receptorblockers which reduce stomach acid secretion and other drugs which maycompletely block stomach acid. However, while pharmacologic agents mayprovide short term relief, they do not address the underlying cause ofLES dysfunction.

[0009] Invasive procedures requiring percutaneous introduction ofinstrumentation into the abdomen exist for the surgical correction ofGERD. One such procedure, Nissen fundoplication, involves constructing anew “valve” to support the LES by wrapping the gastric fundus around thelower esophagus. Although the operation has a high rate of success, itis an open abdominal procedure with the usual risks of abdominal surgeryincluding: postoperative infection, herniation at the operative site,internal hemorrhage and perforation of the esophagus or of the cardia.In fact, a recent 10 year, 344 patient study reported the morbidity ratefor this procedure to be 17% and mortality 1% (Urschel, J D:Complications Of Antireflux Surgery, Am J Surg 166(1): 68-70; (1993July)). This rate of complication drives up both the medical cost andconvalescence period for the procedure and may exclude portions ofcertain patient populations (e.g., the elderly and immuno-compromised).

[0010] Efforts to perform Nissen fundoplication by less invasivetechniques have resulted in the development of laparoscopic Nissenfundoplication. Laparoscopic Nissen fundoplication, reported byDallemagne et al. Surgical Laparoscopy and Endoscopy, Vol. 1, No. 3,(1991), pp. 138-43 and by Hindler et al. Surgical Laparoscopy andEndoscopy, Vol. 2, No. 3, (1992), pp. 265-272, involves essentially thesame steps as Nissen fundoplication with the exception that surgicalmanipulation is performed through a plurality of surgical cannulaintroduced using trocars inserted at various positions in the abdomen.

[0011] Another attempt to perform fundoplication by a less invasivetechnique is reported in U.S. Pat. No. 5,088,979. In this procedure aninvagination device containing a plurality of needles is insertedtransorally into the esophagus with the needles in a retracted position.The needles are extended to engage the esophagus and fold the attachedesophagus beyond the gastroesophageal junction. A remotely operatedstapling device, introduced percutaneously through an operating channelin the stomach wall, is actuated to fasten the invaginatedgastroesophageal junction to the surrounding involuted stomach wall.

[0012] Yet another attempt to perform fundoplication by a less invasivetechnique is reported in U.S. Pat. No. 5,676,674. In this procedure,invagination is done by ajaw-like device and fastening of theinvaginated gastroesophageal junction to the findus of the stomach isdone via a transoral approach using a remotely operated fasteningdevice, eliminating the need for an abdominal incision. However, thisprocedure is still traumatic to the LES and presents the postoperativerisks of gastroesophageal leaks, infection and foreign body reaction,the latter two sequela resulting when foreign materials such as surgicalstaples are implanted in the body.

[0013] While the methods reported above are less invasive than an openNissen fundoplication, some still involve making an incision into theabdomen and hence the increased morbidity and mortality risks andconvalescence period associated with abdominal surgery. Others incur theincreased risk of infection associated with placing foreign materialsinto the body. All involve trauma to the LES and the risk of leaksdeveloping at the newly created gastroesophageal junction.

[0014] Besides the LES, there are other sphincters in the body which ifnot functionally properly can cause disease states or otherwiseadversely affect the lifestyle of the patient. Reduced muscle tone orotherwise aberrant relaxation of sphincters can result in a laxity oftightness disease states including, but not limited to, urinaryincontinence.

[0015] There is a need to provide an apparatus to treat a sphincter andreduce a frequency of sphincter relaxation. Another need exists for anapparatus to create controlled cell necrosis in a sphincter tissueunderlying a sphincter mucosal layer. Yet another need exists for anapparatus to create cell necrosis in a sphincter and minimize injury toa mucosal layer of the sphincter. There is another need for an apparatusto controllably produce a lesion in a sphincter without creating apermanent impairment of the sphincter's ability to achieve aphysiologically normal state of closure. Still a further need exists foran apparatus to create a tightening of a sphincter without permanentlydamaging anatomical structures near the sphincter. There is stillanother need for an apparatus to create cell necrosis in a loweresophageal sphincter to reduce a frequency of reflux of stomach contentsinto an esophagus.

SUMMARY OF THE INVENTION

[0016] Accordingly, an object of the present invention is to provide anapparatus to treat a sphincter and reduce a frequency of sphincterrelaxation.

[0017] Another object of the invention is to provide an apparatus tocreate controlled cell necrosis in a sphincter tissue underlying asphincter mucosal layer.

[0018] Yet another object of the invention is to provide an apparatus tocreate cell necrosis in a sphincter and minimize injury to a mucosallayer of the sphincter.

[0019] A further object of the invention is to provide an apparatus tocontrollably produce a lesion in a sphincter without creating apermanent impairment of the sphincter's ability to achieve aphysiologically normal state of closure.

[0020] Still another object of the invention is to provide an apparatusto create a tightening of a sphincter without permanently damaginganatomical structures near the sphincter.

[0021] Another object of the invention is to provide an apparatus tocreate cell necrosis in a lower esophageal sphincter to reduce afrequency of reflux of stomach contents into an esophagus.

[0022] Yet another object of the invention is to provide an apparatus toreduce the frequency and severity of gastroesophageal reflux events.

[0023] These and other objects of the invention are provided in asphincter treatment apparatus. The apparatus includes an energy deliverydevice introduction member including a plurality of arms. Each arm hasdistal and proximal ends. The distal ends of the arms are coupled as arethe proximal ends of the arms. The energy delivery device introductionmember is configured to be introduced in the sphincter in a non-deployedstate, expand to a deployed state to at least partially dilate thesphincter. A plurality of energy delivery devices are coupled to theenergy delivery device introduction member. At least a portion of theplurality of energy delivery devices are controllably introducible fromthe energy delivery device introduction member into the sphincter.

[0024] In another embodiment, the sphincter treatment apparatus has anexpandable basket structure. An expandable basket structure includes afirst arm with a distal and a proximal section, a second arm with adistal and a proximal section, and a third arm with a distal and aproximal section. The proximal sections of the first, second and thirdarms are coupled to each other. The distal sections of the first, secondand third arms are coupled to each other. The expanded basket structurehas a non-deployed state and a deployed state where the first, secondand third arms distend away from each other. A first energy deliverydevice is coupled to the first arm and includes a distal portioncontrollably advanceable from the first arm into the sphincter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025]FIG. 1 is an illustrated lateral view of the upper GI tractincluding the esophagus and lower esophageal sphincter and thepositioning of the sphincter treatment apparatus of the presentinvention in the lower esophageal sphincter.

[0026]FIG. 2A is a lateral view of the present invention illustratingthe energy delivery device, power supply and expansion device in anexpanded and contracted state.

[0027]FIG. 2B is a lateral view of an embodiment of the inventionillustrating the use of a slotted introducer to facilitate contact ofthe expansion device with esophageal wall.

[0028]FIG. 3 depicts a lateral view of the present invention thatillustrates components on the flexible shaft including a proximalfitting, connections and proximal and distal shaft segments.

[0029]FIG. 4A illustrates a lateral view of the basket assembly used inan embodiment of the invention.

[0030]FIG. 4B illustrates a lateral view of a basket assembly with atapered tip.

[0031]FIG. 5A is a lateral view of the basket assembly that illustratesthe range of camber in the basket assembly.

[0032]FIG. 5B is a perspective view illustrating a balloon coupled tothe basket assembly.

[0033]FIG. 6A is a lateral view of the junction between the basket armsand the shaft illustrating the pathway used for advancement of themovable wire or the delivery of fluids.

[0034]FIG. 6B is a frontal view of a basket arm in an alternativeembodiment of the invention illustrating a track in the arm used toadvance the movable wire.

[0035]FIG. 7 is a cross-sectional view of a section of the basket armillustrating stepped and tapered sections in basket arm apertures.

[0036]FIG. 8 is a lateral view of the basket assembly illustrating theplacement of the radial supporting member.

[0037]FIG. 9A is a lateral view of the sphincter treatment apparatusillustrating the mechanism used in one embodiment of the invention toincrease the camber of the basket assembly.

[0038]FIG. 9B is a similar view to 9A showing the basket assembly in anincreased state of camber.

[0039]FIG. 10 is a lateral view of the sphincter treatment apparatusillustrating the deflection mechanism.

[0040]FIG. 11 is a lateral view illustrating the use of electrolyticsolution to create an enhanced RF electrode.

[0041]FIG. 12 is a lateral view of the basket assembly illustrating theuse of needle electrodes.

[0042]FIG. 13 is a lateral view illustrating the use of an insulationsegment on the needle electrode to protect an area of tissue from RFenergy.

[0043]FIG. 14 is a lateral view illustrating the placement of needleelectrodes into the sphincter wall by expansion of the basket assembly.

[0044]FIG. 15 is a lateral view illustrating placement of needleelectrodes into the sphincter wall by advancement of an electrodedelivery member out of apertures in the basket arms.

[0045]FIG. 16 is a cross sectional view illustrating the configurationof a basket arm aperture used to select and maintain a penetration angleof the needle electrode into the sphincter wall.

[0046]FIG. 17A is a lateral view illustrating placement of needleelectrodes into the sphincter wall by advancement of an electrodedelivery member directly out of the distal end of the shaft.

[0047]FIG. 17B is a lateral view illustrating the use of a needle hub tofacilitate placement of needle electrodes into the sphincter wall.

[0048]FIG. 18A is a lateral view illustrating a radial distribution ofelectrodes on the expansion device of the invention.

[0049]FIG. 18B is a lateral view illustrating a longitudinaldistribution of electrodes on the expansion device of the invention.

[0050]FIG. 18C is a lateral view illustrating a spiral distribution ofelectrodes on the expansion device of the invention.

[0051]FIG. 19 is a flow chart illustrating a sphincter treatment methodusing the apparatus of the present invention.

[0052]FIG. 20 is a lateral view of sphincter smooth muscle tissueillustrating electromagnetic foci and pathways for the origination andconduction of aberrant electrical signals in the smooth muscle of thelower esophageal sphincter or other tissue.

[0053]FIG. 21 is a lateral view of a sphincter wall illustrating theinfiltration of tissue healing cells into a lesion in the smooth tissueof a sphincter following treatment with the sphincter treatmentapparatus of the present invention.

[0054]FIG. 22 is a view similar to that of FIG. 21 illustratingshrinkage of the lesion site caused by cell infiltration.

[0055]FIG. 23 is a lateral view of the esophageal wall illustrating thepreferred placement of lesions in the smooth muscle layer of aesophageal sphincter.

[0056]FIG. 24 is a lateral view illustrating the ultrasound transducer,ultrasound lens and power source of an embodiment of the presentinvention.

[0057] FIGS. 25A-D are lateral views of the sphincter wall illustratingvarious patterns of lesions created by the apparatus of the presentinvention.

[0058]FIG. 26 is a lateral view of the sphincter wall illustrating thedelivery of cooling fluid to the electrode-tissue interface and thecreation of cooling zones.

[0059]FIG. 27 depicts the flow path, fluid connections and control unitemployed to deliver fluid to the electrode-tissue interface.

[0060]FIG. 28 depicts the flow path, fluid connections and control unitemployed to deliver fluid to the RF electrodes.

[0061]FIG. 29 is an enlarged lateral view illustrating the placement ofsensors on the expansion device or basket assembly.

[0062]FIG. 30 depicts a block diagram of the feed back control systemthat can be used with the sphincter treatment apparatus.

[0063]FIG. 31 depicts a block diagram of an analog amplifier, analogmultiplexer and microprocessor used with the feedback control system ofFIG. 30.

[0064]FIG. 32 depicts a block diagram of the operations performed in thefeedback control system depicted in FIG. 30.

DETAILED DESCRIPTION

[0065] Referring now to FIGS. 1 and 2, one embodiment of sphinctertreatment apparatus 10 that is used to deliver energy to a treatmentsite 12 to produce lesions 14 in a sphincter 16, such as the loweresophageal sphincter (LES), comprises a flexible elongate shaft 18, alsocalled shaft 18, coupled to a expansion device 20, in turn coupled withone or more energy delivery devices 22. Energy delivery devices 22 areconfigured to be coupled to a power source 24. The expansion device 20is configured to be positionable in a sphincter 16 such as the LES oradjacent anatomical structure, such as the cardia of the stomach.Expansion device 20 is further configured to facilitate the positioningof energy delivery devices 22 to a selectable depth in a sphincter wall26 or adjoining anatomical structure. Expansion device 20 has a centrallongitudinal axis 28 and is moveable between contracted and expandedpositions substantially there along. This can be accomplished by aratchet mechanism as is known to those skilled in the art. At leastportions of sphincter treatment apparatus 10 may be sufficientlyradiopaque in order to be visible under fluoroscopy and/or sufficientlyechogenic to be visible under ultrasonography. Also as will be discussedherein, sphincter treatment apparatus 10 can include visualizationcapability including, but not limited to, a viewing scope, an expandedeyepiece, fiber optics, video imaging and the like.

[0066] Referring to FIG. 2A, shaft 18 is configured to be coupled toexpansion device 20 and has sufficient length to position expansiondevice 20 in the LES and/or stomach using a transoral approach. Typicallengths for shaft 18 include, but are not limited to, a range of 40-180cms. In various embodiments, shaft 18 is flexible, articulated andsteerable and can contain fiber optics (including illumination andimaging fibers), fluid and gas paths, and sensor and electronic cabling.In one embodiment, shaft 18 can be a multi-lumen catheter, as is wellknown to those skilled in the art.

[0067] In another embodiment, an introducing member 21, also called anintroducer, is used to introduce sphincter treatment apparatus 10 intothe LES. Introducer 21 can also function as a sheath for expansiondevice 20 to keep it in a nondeployed or contracted state duringintroduction into the LES. In various embodiments, introducer 21 isflexible, articulated and steerable and contains a continuous lumen ofsufficient diameter to allow the advancement of sphincter treatmentapparatus 10. Typical diameters for introducer 21 include 0.1 to 2inches, while typical length include 40-180 cms. Introducer 21 may be ofsufficient length and width to extend into a portion of or past the LESand provide structural support to and/or immobilize the esophagus. Thisserves to reduce movement of the esophagus and/or expansion device 20 soas to facilitate introduction of a needle electrode (described herein)into sphincter wall 26. As shown in FIG. 2B, introducer 21 may alsocontain slots 25 near introducer distal end 21′ or at other points alongits length. Slots 25 are of sufficient length and width to allowexpansion device 20 to engage sphincter wall 26 when it is put into adeployed state inside introducer 21. Suitable materials for introducer21 include coil-reinforced plastic tubing as is well known to thoseskilled in the art.

[0068] Referring now to FIG. 3, the flexible elongate shaft 18 iscircular in cross section and has proximal and distal extremities (alsocalled ends) 30 and 32. Shaft 18 may also be coupled at its proximal end32 to a proximal fitting 34, also called a handle, used by the physicianto manipulate sphincter treatment apparatus 10 to reach treatment site12. Shaft 18 may have one or more lumens 36, that extend the full lengthof shaft 18, or part way from shaft proximal end 30 to shaft distal end32. Lumens 36 may be used as paths for catheters, guide wires, pullwires, insulated wires and cabling, fluid and optical fibers. Lumens 36are connected to and/or accessed by connections 38 on or adjacent toproximal fitting 34. Connections 38 can include luer-lock, lemoconnector, swage and other mechanical varieties well known to thoseskilled in the art. Connections 38 can also include optical/videoconnections which allow optical and electronic coupling of opticalfibers and/or viewing scopes to illuminating sources, eye pieces andvideo monitors. In various embodiments, shaft 18 may stop at theproximal extremity 40 of expansion device 20 or extend to, or past, thedistal extremity 42 of expansion device 20. Suitable materials for shaft18 include, but are not limited to, polyethylenes, polyurethanes andother medical plastics known to those skilled in the art.

[0069] Referring now to FIG. 4A, in one embodiment of the presentinvention expansion device 20 comprises one or more elongated arms 44that are joined at their proximal ends 46 and distal ends 48 to form abasket assembly 50. Proximal arm end 46 is attached to a supportingstructure, which can be the distal end 32 of shaft 18 or a proximal cap51. Likewise, distal arm end 48 is also attached to a supportingstructure which can be a basket cap 52 or shaft 18. In one embodimentshown in FIG. 4B, basket cap 52 can be a tapered cap 52′ to facilitateinsertion through the folds of the LES.

[0070] Attached arms 44 may form a variety of geometric shapesincluding, but not limited to, curved, rectangular, trapezoidal andtriangular. Arms 44 can have a variety of cross sectional geometriesincluding, but not limited to, circular, rectangular andcrescent-shaped. Also, arms 44 are of a sufficient number (two or more),and have sufficient spring force (0.01 to 0.5 lbs. force ) so as tocollectively exert adequate force on sphincter wall 26 to sufficientlyopen and efface the folds of sphincter 16 to allow treatment withsphincter treatment apparatus 10, while preventing herniation ofsphincter wall 26 into the spaces 53 between arms 44. Suitable materialsfor arms 44 include, but are not limited to, spring steel, stainlesssteel, superelastic shape memory metals such as nitinol or wirereinforced plastic tubing as is well known to those skilled in the art.In another embodiment, arms 44 may have an external layer of texturizedmaterial 45 that has sufficient friction to immobilize the area near andaround sphincter wall 26 contacted by arm 44. Suitable materials fortexturized material 45 include knitted Dacron® and Dacron velour.

[0071] Referring to FIG. 5A, arms 44 can have an outwardly bowed shapedmemory for expanding the basket assembly into engagement with sphincterwall 26 with the amount of bowing, or camber 54 being selectable from arange 0 to 2 inches from longitudinal axis 28 of basket assembly 50. Forthe case of a curve-shaped arm 44′, expanded arms 44 arecircumferentially and symmetrically spaced-apart. In various otherembodiments (not shown), arms 44 may be asymmetrically spaced and/ordistributed on an arc less than 360°. Also, arms 44 may be preshaped attime of manufacture or shaped by the physician.

[0072] In another embodiment shown in FIG. 5B, an expandable member 55,which can be a balloon, is coupled to an interior or exterior of basketassembly 50. Balloon 55 is also coupled to and inflated by lumen 36using gas or liquid. Balloon 55 may be made of a textured material, orhave a texturized layer 55′ that when engaged with sphincter wall 26,provides sufficient friction to at least partially immobilize thesurface of sphincter wall 26. Suitable materials for texturized layer55′ include knitted Dacron and Dacron velour.

[0073] Referring now to FIG. 6A, arms 44 may also be solid or hollowwith a continuous lumen 58 that may be coupled with shaft lumens 36.These coupled lumens provide a path for the delivery of a fluid orelectrode delivery member 60 (also called an advancement member) fromshaft 18 to any point on basket assembly 50. In various embodimentselectrode delivery member 60 can be an insulated wire, an insulatedguide wire, a plastic-coated stainless steel hypotube with internalwiring or a plastic catheter with internal wiring, all of which areknown to those skilled in the art. As shown in FIG. 6B, arms 44 may alsohave a partially open channel 62, also called a track 62, that functionsas a guide track for electrode delivery member 60. Referring back toFIG. 6A, arms 44 may have one or more apertures 64 at any point alongtheir length that permit the controlled placement of energy deliverydevices 22 at or into sphincter wall 26. Referring now to FIG. 7,apertures 64 may have tapered sections 66 or stepped sections 68 in allor part of their length, that are used to control the penetration depthof energy delivery devices 22 into sphincter wall 26. Referring back toFIG. 6A, apertures 64 in combination with arm lumens 58 and shaft lumens36 may be used for the delivery of cooling solution 70 or electrolyticsolution 72 to treatment site 12 as described herein. Additionally, arms44 can also carry a plurality of longitudinally spaced apart radiopaqueand or echogenic markers or traces, not shown in the drawings, formed ofsuitable materials to permit viewing of basket assembly 50 viafluoroscopy or ultrasonography. Suitable radiopaque materials includeplatinum or gold, while suitable echogenic materials include gas filledmicro-particles as described in U.S. Pat. Nos. 5,688,490 and 5,205,287.Arms 44 may also be color-coded to facilitate their identification viavisual medical imaging methods and equipment, such as endoscopicmethods, which are well known to those skilled in the art.

[0074] In another embodiment of the present invention, a supportingmember 74 is attached to two or more arms 44. Supporting member 74, alsocalled a strut, can be attached to arms 44 along a circumference ofbasket assembly 50 as shown in FIG. 8. Apertures 64 can extend throughradial supporting member 74 in one or more places. Radial supportingmember 74 serves the following functions: i) facilitates opening andeffacement of the folds of sphincter 16, ii) enhances contact ofApertures 64 with sphincter wall 26; and, iii) reduces or prevents thetendency of arms 44 to bunch up. The cross sectional geometry of radialsupporting member 74 can be rectangular or circular, though it will beappreciated that other geometries are equally suitable.

[0075] In one embodiment shown in FIG. 9, arms 44 are attached to basketcap 52 that in turn, moves freely over shaft 18, but is stopped distallyby shaft cap 78. One or more pull wires 80 are attached to basket cap 52and also to a movable fitting 82 in proximal fitting 34 of sphinctertreatment apparatus 10. When pull wire 80 is pulled back by movablefitting 82, the camber 54 of basket assembly 50 increases to 54′,increasing the force and the amount of contact applied by basketassembly 50 to sphincter wall 26 or an adjoining structure. Basketassembly 50 can also be deflected from side to side using deflectionmechanism 80. This allows the physician to remotely point and steer thebasket assembly within the body. In one embodiment shown in FIG. 10,deflection mechanism 84 includes a second pull wire 80′ attached toshaft cap 78 and also to a movable slide 86 integral to proximal fitting34.

[0076] Turning now to a discussion of energy delivery, suitable powersources 24 and energy delivery devices 22 that can be employed in one ormore embodiments of the invention include: (i) a radio-frequency (RF)source coupled to an RF electrode, (ii) a coherent source of lightcoupled to an optical fiber, (iii) an incoherent light source coupled toan optical fiber, (iv) a heated fluid coupled to a catheter with aclosed channel configured to receive the heated fluid, (v) a heatedfluid coupled to a catheter with an open channel configured to receivethe heated fluid, (vi) a cooled fluid coupled to a catheter with aclosed channel configured to receive the cooled fluid, (vii) a cooledfluid coupled to a catheter with an open channel configured to receivethe cooled fluid, (viii) a cryogenic fluid, (ix) a resistive heatingsource, (x) a microwave source providing energy from 915 MHz to 2.45 GHzand coupled to a microwave antenna, (xi) an ultrasound power sourcecoupled to an ultrasound emitter, wherein the ultrasound power sourceproduces energy in the range of 300 KHZ to 3 GHz, or (xii) a microwavesource. For ease of discussion for the remainder of this application,the power source utilized is an RF source and energy delivery device 22is one or more RF electrodes 88, also described as electrodes 88.However, all of the other herein mentioned power sources and energydelivery devices are equally applicable to sphincter treatment apparatus10.

[0077] For the case of RF energy, RF electrode 88 may operated in eitherbipolar or monopolar mode with a ground pad electrode. In a monopolarmode of delivering RF energy, a single electrode 88 is used incombination with an indifferent electrode patch that is applied to thebody to form the other electrical contact and complete an electricalcircuit. Bipolar operation is possible when two or more electrodes 88are used. Multiple electrodes 88 may be used. These electrodes may becooled as described herein. Electrodes 88 can be attached to electrodedelivery member 60 by the use of soldering methods which are well knownto those skilled in the art. Suitable solders include Megabond Soldersupplied by the Megatrode Corporation (Milwaukee, Wis.).

[0078] Suitable electrolytic solutions 72 include saline, solutions ofcalcium salts, potassium salts, and the like. Electrolytic solutions 72enhance the electrical conductivity of the targeted tissue at thetreatment site 12. When a highly conductive fluid such as electrolyticsolution 72 is infused into tissue the electrical resistance of theinfused tissue is reduced, in turn, increasing the electricalconductivity of the infused tissue. As a result, there will be littletendency for tissue surrounding electrode 88 to desiccate (a conditiondescribed herein that increases the electrical resistance of tissue)resulting in a large increase in the capacity of the tissue to carry RFenergy. Referring to FIG. 11, a zone of tissue which has been heavilyinfused with a concentrated electrolytic solution 72 can become soconductive as to actually act as an enhanced electrode 88′. The effectof enhanced electrode 88′ is to increase the amount of current that canbe conducted to the treatment site 12, making it possible to heat a muchgreater volume of tissue in a given time period.

[0079] Also when the power source is RF, power source 24, which will nowbe referred to as RF power source 24, may have multiple channels,delivering separately modulated power to each electrode 88. This reducespreferential heating that occurs when more energy is delivered to a zoneof greater conductivity and less heating occurs around electrodes 88which are placed into less conductive tissue. If the level of tissuehydration or the blood infusion rate in the tissue is uniform, a singlechannel RF power source 24 may be used to provide power for generationof lesions 14 relatively uniform in size.

[0080] Electrodes 88 can have a variety of shapes and sizes. Possibleshapes include, but are not limited to, circular, rectangular, conicaland pyramidal. Electrode surfaces can be smooth or textured and concaveor convex. The conductive surface area of electrode 88 can range from0.1 mm² to 100 cm². It will be appreciated that other geometries andsurface areas may be equally suitable. In one embodiment, electrodes 88can be in the shape of needles and of sufficient sharpness and length topenetrate into the smooth muscle of the esophageal wall, sphincter 16 orother anatomical structure. In this embodiment shown in FIGS. 12 and 13,needle electrodes 90 are attached to arms 44 and have an insulatinglayer 92, covering an insulated segment 94 except for an exposed segment95. For purposes of this disclosure, an insulator or insulation layer isa barrier to either thermal, RF or electrical energy flow. Insulatedsegment 94 is of sufficient length to extend into sphincter wall 26 andminimize the transmission of RF energy to a protected site 97 near oradjacent to insulated segment 94 (see FIG. 13). Typical lengths forinsulated segment 94 include, but are not limited to, 1-4 mms. Suitablematerials for needle electrodes 90 include, but are not limited to, 304stainless steel and other stainless steels known to those skilled in theart. Suitable materials for insulating layer 92 include, but are notlimited to, polyimides and polyamides.

[0081] During introduction of sphincter treatment apparatus 10, basketassembly 50 is in a contracted state. Once sphincter treatment apparatus10 is properly positioned at the treatment site 12, needle electrodes 90are deployed by expansion of basket assembly 50, resulting in theprotrusion of needle electrodes 90 into the smooth muscle tissue ofsphincter wall 26 (refer to FIG. 14). The depth of needle penetration isselectable from a range of 0.5 to 5 mms and is accomplished by indexingmovable fitting 82 so as to change the camber 54 of arm 44 in fixedincrements that can be selectable in a range from 0.1 to 4 mms. Needleelectrodes 90 are coupled to power source 24 via insulated wire 60.

[0082] In another embodiment of sphincter treatment apparatus 10 shownin FIG. 15, needle electrodes 90 are advanced out of apertures 64 inbasket arms 44 into the smooth muscle of the esophageal wall or othersphincter 16. In this case, needle electrodes 90 are coupled to RF powersource 24 by electrode delivery member 60. In this embodiment, the depthof needle penetration is selectable via means of stepped sections 66 ortapered sections 68 located in apertures 64. Referring to FIG. 16,apertures 64 and needle electrodes 90 are configured such that thepenetration angle 96 (also called an emergence angle 96) of needleelectrode 90 into sphincter wall 26 remains sufficiently constant duringthe time needle electrode 90 is being inserted into sphincter wall 26,such that there is no tearing or unnecessary trauma to sphincter walltissue. This is facilitated by the selection of the following parametersand criteria: i) the emergence angle 96 of apertures 64 which can varyfrom 1 to 90°, ii) the arc radius 98 of the curved section 100 ofaperture 64 which can vary from 0.001 to 2 inch, iii) the amount ofclearance between the aperture inner diameter 102 and the needleelectrode outside diameter 104 which can very between 0.001″ and 0.1″;and, iv) use of a lubricous coating on electrode delivery member 60 suchas a Teflon® or other coatings well known to those skilled in the art.Also in this embodiment, insulated segment 94 can be in the form of ansleeve that may be adjustably positioned at the exterior of electrode90.

[0083] In another alternative embodiment shown in FIG. 17A , electrodedelivery member 60 with attached needle electrodes 90, can exit fromlumen 36 at distal shaft end 32 and be positioned into contact withsphincter wall 26. This process may be facilitated by use of a hollowguiding member 101, known to those skilled in the art as a guidingcatheter, through which electrode delivery member 60 is advanced.Guiding catheter 101 may also include stepped sections 66 or taperedsections 68 at it distal end to control the depth of penetration ofneedle electrode 90 into sphincter wall 26.

[0084] In an alternative embodiment shown in FIG. 17B, needle electrodes90 can be advanced through an aperture 64′ in needle hub 103 (locatedinside basket assembly 50) and subsequently advanced through aperture 64in arm 44 and into sphincter wall 26. Aperture 64′ has proximal anddistal ends 64″ and 64′″. Also needle hub 103 is configured to becoupled to delivery member 60 or basket assembly 50 and serves as aguiding tool to facilitate penetration of needle electrode 90 intosphincter wall 26. In one embodiment, proximal and distal ends 64″ and64′″ of apertures 64′ are located in different planes.

[0085] RF energy flowing through tissue causes heating of the tissue dueto absorption of the RF energy by the tissue and ohmic heating due toelectrical resistance of the tissue. This heating can cause injury tothe affected cells and can be substantial enough to cause cell death, aphenomenon also known as cell necrosis. For ease of discussion for theremainder of this application, cell injury will include all cellulareffects resulting from the delivery of energy from electrode 88 up to,and including, cell necrosis. Cell injury can be accomplished as arelatively simple medical procedure with local anesthesia. In oneembodiment, cell injury proceeds to a depth of approximately 1-4 mmsfrom the surface of the mucosal layer of sphincter 16 or that of anadjoining anatomical structure.

[0086] Referring now to FIGS. 18A, 18B and 18C, electrodes 88 and/orapertures 64 may be distributed in a variety of patterns along expansiondevice 20 or basket assembly 50 in order to produce a desired placementand pattern of lesions 14. Typical electrode and aperture distributionpatterns include, but are not limited to, a radial distribution 105(refer to FIG. 18A) or a longitudinal distribution 106 (refer to FIG.18B). It will be appreciated that other patterns and geometries forelectrode and aperture placement, such as a spiral distribution 108(refer to FIG. 18C) may also be suitable. These electrodes may be cooledas described hereafter.

[0087]FIG. 19 is a flow chart illustrating one embodiment of theprocedure for using sphincter treatment apparatus 10. In thisembodiment, sphincter treatment apparatus 10 is first introduced intothe esophagus under local anesthesia. Sphincter treatment apparatus 10can be introduced into the esophagus by itself or through a lumen in anendoscope (not shown), such as disclosed in U.S. Pat. Nos. 5,448,990 and5,275,608, incorporated herein by reference, or similar esophagealaccess device known to those skilled in the art. Basket assembly 50 isexpanded and can be done through slots 25 in introducer 21 as describedherein. This serves to temporarily dilate the LES or sufficiently toefface a portion of or all of the folds of the LES. In an alternativeembodiment, esophageal dilation and subsequent LES fold effacement canbe accomplished by insufflation of the esophagus (a known technique)using gas introduced into the esophagus through shaft lumen 36, or anendoscope or similar esophageal access device as described above. Oncetreatment is completed, basket assembly 50 is returned to itspredeployed or contracted state and sphincter treatment apparatus 10 iswithdrawn from the esophagus. This results in the LES returning toapproximately its pretreatment state and diameter. It will beappreciated that the above procedure is applicable in whole or part tothe treatment of other sphincters in the body.

[0088] The diagnostic phase of the procedure can be performed using avariety of diagnostic methods, including, but not limited to, thefollowing: (i) visualization of the interior surface of the esophagusvia an endoscope or other viewing apparatus inserted into the esophagus,(ii) visualization of the interior morphology of the esophageal wallusing ultrasonography to establish a baseline for the tissue to betreated, (iii) impedance measurement to determine the electricalconductivity between the esophageal mucosal layers and sphinctertreatment apparatus 10 and (iv) measurement and surface mapping of theelectropotential of the LES during varying time periods which mayinclude such events as depolarization, contraction and repolarization ofLES smooth muscle tissue. This latter technique is done to determinetarget treatment sites 12 in the LES or adjoining anatomical structuresthat are acting as foci 107 or pathways 109 for abnormal orinappropriate polarization and relaxation of the smooth muscle of theLES (Refer to FIG. 20).

[0089] In the treatment phase of the procedure, the delivery of energyto treatment site 12 can be conducted under feedback control, manuallyor by a combination of both. Feedback control (described herein) enablessphincter treatment apparatus 10 to be positioned and retained in theesophagus during treatment with minimal attention by the physician.Electrodes 88 can be multiplexed in order to treat the entire targetedtreatment site 12 or only a portion thereof. Feedback can be includedand is achieved by the use of one or more of the following methods: (i)visualization, (ii) impedance measurement, (iii) ultrasonography, (iv)temperature measurement; and, (v) sphincter contractile forcemeasurement via manometry. The feedback mechanism permits the selectedon-off switching of different electrodes 88 in a desired pattern, whichcan be sequential from one electrode 88 to an adjacent electrode 88, orcan jump around between non-adjacent electrodes 88. Individualelectrodes 88 are multiplexed and volumetrically controlled by acontroller.

[0090] The area and magnitude of cell injury in the LES or sphincter 16can vary. However, it is desirable to deliver sufficient energy to thetargeted treatment site 12 to be able to achieve tissue temperatures inthe range of 55-95° C. and produce lesions 14 at depths ranging from 1-4mms from the interior surface of the LES or sphincter wall 26. Typicalenergies delivered to the esophageal wall include, but are not limitedto, a range between 100 and 50,000 joules per electrode 88. It is alsodesirable to deliver sufficient energy such that the resulting lesions14 have a sufficient magnitude and area of cell injury to cause aninfiltration of lesion 14 by fibroblasts 110, myofibroblasts 112,macrophages 114 and other cells involved in the tissue healing process(refer to FIG. 21). As shown in FIG. 22, these cells cause a contractionof tissue around lesion 14, decreasing its volume and, or altering thebiomechanical properties at lesion 14 so as to result in a tightening ofLES or sphincter 16. These changes are reflected in transformed lesion14′ shown in FIG. 19B. The diameter of lesions 14 can vary between 0.1to 4 mms. It is preferable that lesions 14 are less than 4 mms indiameter in order to reduce the risk of thermal damage to the mucosallayer. In one embodiment, a 2 mm diameter lesion 14 centered in the wallof the smooth muscle provides a 1 mm buffer zone to prevent damage tothe mucosa, submucosa and adventitia, while still allowing for cellinfiltration and subsequent sphincter tightening on approximately 50% ofthe thickness of the wall of the smooth muscle (refer to FIG. 23).

[0091] From a diagnostic standpoint, it is desirable to image theinterior surface and wall of the LES or other sphincter 16, includingthe size and position of created lesions 14. It is desirable to create amap of these structures which can input to a controller and used todirect the delivery of energy to the treatment site. Referring to FIG.24, this can be accomplished through the use of ultrasonography (a knownprocedure) which involves the use of an ultrasound power source 116coupled to one or more ultrasound transducers 118 that are positioned onexpansion device 20 or basket assembly 50. An output is associated withultrasound power source 116.

[0092] Each ultrasound transducer 118 can include a piezoelectriccrystal 120 mounted on a backing material 122 that is in turn, attachedto expansion device 20 or basket assembly 50. An ultrasound lens 124,fabricated on an electrically insulating material 126, is mounted overpiezoelectric crystal 120. Piezoelectric crystal 120 is connected byelectrical leads 128 to ultrasound power source 116 Each ultrasoundtransducer 118 transmits ultrasound energy into adjacent tissue.Ultrasound transducers 118 can be in the form of an imaging probe suchas Model 21362, manufactured and sold by Hewlett Packard Company, PaloAlto, Calif. In one embodiment, two ultrasound transducers 118 arepositioned on opposite sides of expansion device 20 or basket assembly50 to create an image depicting the size and position of lesion 14 inselected sphincter 16.

[0093] It is desirable that lesions 14 are predominantly located in thesmooth muscle layer of selected sphincter 16 at the depths ranging from1 to 4 mms from the interior surface of sphincter wall 26. However,lesions 14 can vary both in number and position within sphincter wall26. It may be desirable to produce a pattern of multiple lesions 14within the sphincter smooth muscle tissue in order to obtain a selecteddegree of tightening of the LES or other sphincter 16. Typical lesionpatterns shown in FIGS. 25A-D include, but are not limited to, (i) aconcentric circle of lesions 14 all at fixed depth in the smooth musclelayer evenly spaced along the radial axis of sphincter 16, (ii) a wavyor folded circle of lesions 14 at varying depths in the smooth musclelayer evenly spaced along the radial axis of sphincter 16, (iii) lesions14 randomly distributed at varying depths in the smooth muscle, butevenly spaced in a radial direction; and, (iv) an eccentric pattern oflesions 14 in one or more radial locations in the smooth muscle wall.Accordingly, the depth of RF and thermal energy penetration sphincter 16is controlled and selectable. The selective application of energy tosphincter 16 may be the even penetration of RF energy to the entiretargeted treatment site 12, a portion of it, or applying differentamounts of RF energy to different sites depending on the condition ofsphincter 16. If desired, the area of cell injury can be substantiallythe same for every treatment event.

[0094] Referring to FIG. 26, it may be desirable to cool all or aportion of the area near the electrode-tissue interface 130 before,during or after the delivery of energy in order to reduce the degree andarea of cell injury. Specifically, the use of cooling preserves themucosal layers of sphincter wall 26 and protects, or otherwise reducesthe degree of cell damage to cooled zone 132 in the vicinity of lesion14. Referring now to FIG. 27, this can be accomplished through the useof cooling solution 70 that is delivered by apertures 64 which is influid communication with shaft lumen 36 that is, in turn, in fluidcommunication with fluid reservoir 134 and a control unit 136, whoseoperation is described herein, that controls the delivery of the fluid.

[0095] Similarly, it may also be desirable to cool all or a portion ofthe electrode 88. The rapid delivery of heat through electrode 88, mayresult in the build up of charred biological matter on electrode 88(from contact with tissue and fluids e.g., blood) that impedes the flowof both thermal and electrical energy from electrode 88 to adjacenttissue and causes an electrical impedance rise beyond a cutoff value seton RF power source 24. A similar situation may result from thedesiccation of tissue adjacent to electrode 88. Cooling of the electrode88 can be accomplished by cooling solution 70 that is delivered byapertures 64 as described previously. Referring now to FIG. 28,electrode 88 may also be cooled via a fluid channel 138 in electrode 88that is in fluid communication with fluid reservoir 134 and control unit136 .

[0096] As shown in FIG. 29, one or more sensors 140 may be positionedadjacent to or on electrode 88 for sensing the temperature of sphinctertissue at treatment site 12. More specifically, sensors 140 permitaccurate determination of the surface temperature of sphincter wall 26at electrode-tissue interface 130. This information can be used toregulate both the delivery of energy and cooling solution 70 to theinterior surface of sphincter wall 26. In various embodiments, sensors140 can be positioned at any position on expansion device 20 or basketassembly 50. Suitable sensors that may be used for sensor 140 include:thermocouples, fiber optics, resistive wires, thermocouple IR detectors,and the like. Suitable thermocouples for sensor 140 include: T type withcopper constantene, J type, E type and K types as are well known thoseskilled in the art.

[0097] Temperature data from sensors 140 are fed back to control unit136 and through an algorithm which is stored within a microprocessormemory of control unit 136. Instructions are sent to an electronicallycontrolled micropump (not shown) to deliver fluid through the fluidlines at the appropriate flow rate and duration to provide controltemperature at the electrode-tissue interface 130 (refer to FIG. 27).

[0098] The reservoir of control unit 136 may have the ability to controlthe temperature of the cooling solution 70 by either cooling the fluidor heating the fluid. Alternatively, a fluid reservoir 134 of sufficientsize may be used in which the cooling solution 70 is introduced at atemperature at or near that of the normal body temperature. Using athermally insulated reservoir 142, adequate control of the tissuetemperature may be accomplished without need of refrigeration or heatingof the cooling solution 70. Cooling solution 70 flow is controlled bycontrol unit 136 or another feedback control system (described herein)to provide temperature control at the electrode-tissue interface 130.

[0099] A second diagnostic phase may be included after the treatment iscompleted. This provides an indication of LES tightening treatmentsuccess, and whether or not a second phase of treatment, to all or onlya portion of the esophagus, now or at some later time, should beconducted. The second diagnostic phase is accomplished through one ormore of the following methods: (i) visualization, (ii) measuringimpedance, (iii) ultrasonography, (iv) temperature measurement, or (v)measurement of LES tension and contractile force via manometry.

[0100] In one embodiment, sphincter treatment apparatus 10 is coupled toan open or closed loop feedback system. Referring now to FIG. 30, anopen or closed loop feedback system couples sensor 346 to energy source392. In this embodiment, electrode 314 is one or more RF electrodes 314.

[0101] The temperature of the tissue, or of RF electrode 314 ismonitored, and the output power of energy source 392 adjustedaccordingly. The physician can, if desired, override the closed or openloop system. A microprocessor 394 can be included and incorporated inthe closed or open loop system to switch power on and off, as well asmodulate the power. The closed loop system utilizes microprocessor 394to serve as a controller, monitor the temperature, adjust the RF power,analyze the result, refeed the result, and then modulate the power.

[0102] With the use of sensor 346 and the feedback control system atissue adjacent to RF electrode 314 can be maintained at a desiredtemperature for a selected period of time without causing a shut down ofthe power circuit to electrode 314 due to the development of excessiveelectrical impedance at electrode 314 or adjacent tissue as is discussedherein. Each RF electrode 314 is connected to resources which generatean independent output. The output maintains a selected energy at RFelectrode 314 for a selected length of time.

[0103] Current delivered through RF electrode 314 is measured by currentsensor 396. Voltage is measured by voltage sensor 398. Impedance andpower are then calculated at power and impedance calculation device 400.These values can then be displayed at user interface and display 402.Signals representative of power and impedance values are received by acontroller 404.

[0104] A control signal is generated by controller 404 that isproportional to the difference between an actual measured value, and adesired value. The control signal is used by power circuits 406 toadjust the power output in an appropriate amount in order to maintainthe desired power delivered at respective RF electrodes 314.

[0105] In a similar manner, temperatures detected at sensor 346 providefeedback for maintaining a selected power. Temperature at sensor 346 isused as a safety means to interrupt the delivery of energy when maximumpre-set temperatures are exceeded. The actual temperatures are measuredat temperature measurement device 408, and the temperatures aredisplayed at user interface and display 402. A control signal isgenerated by controller 404 that is proportional to the differencebetween an actual measured temperature and a desired temperature. Thecontrol signal is used by power circuits 406 to adjust the power outputin an appropriate amount in order to maintain the desired temperaturedelivered at the sensor 346. A multiplexer can be included to measurecurrent, voltage and temperature, at the sensor 346, and energy can bedelivered to RF electrode 314 in monopolar or bipolar fashion.

[0106] Controller 404 can be a digital or analog controller, or acomputer with software. When controller 404 is a computer it can includea CPU coupled through a system bus. This system can include a keyboard,a disk drive, or other non-volatile memory systems, a display, and otherperipherals, as are known in the art. Also coupled to the bus is aprogram memory and a data memory.

[0107] User interface and display 402 includes operator controls and adisplay. Controller 404 can be coupled to imaging systems including, butnot limited to, ultrasound, CT scanners, X-ray, MRI, mammographic X-rayand the like. Further, direct visualization and tactile imaging can beutilized.

[0108] The output of current sensor 396 and voltage sensor 398 are usedby controller 404 to maintain a selected power level at RF electrode314. The amount of RF energy delivered controls the amount of power. Aprofile of the power delivered to electrode 314 can be incorporated incontroller 404 and a preset amount of energy to be delivered may also beprofiled.

[0109] Circuitry, software and feedback to controller 404 result inprocess control, the maintenance of the selected power setting which isindependent of changes in voltage or current, and is used to change thefollowing process variables: (i) the selected power setting, (ii) theduty cycle (e.g., on-off time), (iii) bipolar or monopolar energydelivery; and, (iv) fluid delivery, including flow rate and pressure.These process variables are controlled and varied, while maintaining thedesired delivery of power independent of changes in voltage or current,based on temperatures monitored at sensor 346.

[0110] Referring now to FIG. 31, current sensor 396 and voltage sensor398 are connected to the input of an analog amplifier 410. Analogamplifier 410 can be a conventional differential amplifier circuit foruse with sensor 346. The output of analog amplifier 410 is sequentiallyconnected by an analog multiplexer 412 to the input of A/D converter414. The output of analog amplifier 410 is a voltage which representsthe respective sensed temperatures. Digitized amplifier output voltagesare supplied by AID converter 414 to microprocessor 394. Microprocessor394 may be a type 68HCII available from Motorola. However, it will beappreciated that any suitable microprocessor or general purpose digitalor analog computer can be used to calculate impedance or temperature.

[0111] Microprocessor 394 sequentially receives and stores digitalrepresentations of impedance and temperature. Each digital valuereceived by microprocessor 394 corresponds to different temperatures andimpedances.

[0112] Calculated power and impedance values can be indicated on userinterface and display 402. Alternatively, or in addition to thenumerical indication of power or impedance, calculated impedance andpower values can be compared by microprocessor 394 to power andimpedance limits. When the values exceed predetermined power orimpedance values, a warning can be given on user interface and display402, and additionally, the delivery of RF energy can be reduced,modified or interrupted. A control signal from microprocessor 394 canmodify the power level supplied by energy source 392.

[0113]FIG. 32 illustrates a block diagram of a temperature and impedancefeedback system that can be used to control the delivery of energy totissue site 416 by energy source 392 and the delivery of coolingsolution 70 to electrode 314 and/or tissue site 416 by flow regulator418. Energy is delivered to RF electrode 314 by energy source 392, andapplied to tissue site 416. A monitor 420 ascertains tissue impedance,based on the energy delivered to tissue, and compares the measuredimpedance value to a set value. If the measured impedance exceeds theset value, a disabling signal 422 is transmitted to energy source 392,ceasing further delivery of energy to RF electrode 314. If measuredimpedance is within acceptable limits, energy continues to be applied tothe tissue.

[0114] The control of cooling solution 70 to electrode 314 and/or tissuesite 416 is done in the following manner. During the application ofenergy, temperature measurement device 408 measures the temperature oftissue site 416 and/or RF electrode 314. A comparator 424 receives asignal representative of the measured temperature and compares thisvalue to a preset signal representative of the desired temperature. Ifthe tissue temperature is too high, comparator 424 sends a signal to aflow regulator 418 (connected to an electronically controlled micropump,not shown) representing a need for an increased cooling solution flowrate. If the measured temperature has not exceeded the desiredtemperature, comparator 424 sends a signal to flow regulator 418 tomaintain the cooling solution flow rate at its existing level.

[0115] The foregoing description of a preferred embodiment of theinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Obviously, many modificationsand variations will be apparent to practitioners skilled in this art. Itis intended that the scope of the invention be defined by the followingclaims and their equivalents.

What is claimed is:
 1. A sphincter treatment apparatus, comprising: anenergy delivery device introduction member; a first energy deliverydevice coupled to the energy delivery device introduction member, thefirst energy delivery device having a distal portion, wherein the energydelivery device introduction member is configured to be introduced inthe sphincter in a non-deployed state, and expand to a deployed state toat least partially expand the sphincter; and a retainer member coupledto the energy delivery device introduction member and configured tocontrollably position the energy delivery device introduction member inan orifice of a sphincter.
 2. The apparatus of claim 1, wherein theretainer member retains the energy delivery device introduction memberalong a longitudinal axis of the sphincter.
 3. The apparatus of claim 1,wherein the retainer member reduces a movement of the energy deliverydevice introduction member in the orifice along a longitudinal axis ofthe sphincter.
 4. The apparatus of claim 1, wherein the retainer memberreduces a lateral movement of the energy delivery device introductionmember in the orifice along a longitudinal axis of the sphincter.
 5. Theapparatus of claim 1, wherein the first energy delivery device distalportion is introducible into an interior of the sphincter.
 6. Theapparatus of claim 5, wherein the first energy delivery device is anelectrode.
 7. The apparatus of claim 6, wherein the electrode has atissue piercing distal end.
 8. The apparatus of claim 1, wherein theenergy delivery device introduction member is expandable.
 9. Theapparatus of claim 8, wherein the energy delivery device introductionmember is a balloon.
 10. The apparatus of claim 8, wherein the energydelivery device introduction member is a basket device.
 11. Theapparatus of claim 1, wherein the retainer member is made of a polymericmaterial.
 12. The apparatus of claim 11, wherein the retainer member isa catheter
 13. The apparatus of claim 11, wherein the retainer member isan endoscope
 14. The apparatus of claim 1, wherein the retainer memberreduces a movement of an esophagus.
 15. The apparatus of claim 1,wherein the retainer member has sufficient rigidity to reduce a movementof the sphincter.
 16. The apparatus of claim 15, wherein the retainermember has sufficient rigidity to reduce a movement of an esophagus. 17.The apparatus of claim 1, wherein the first energy delivery device is anRF needle electrode.
 18. The apparatus of claim 17, wherein the retainermember has sufficient rigidity to reduce a movement of the sphincter andreduce an amount of tearing of a sphincter mucosa upon an introductionof the RF needle electrode into the sphincter.
 19. The apparatus ofclaim 17, wherein the retainer member has sufficient rigidity to reducemovement of the sphincter and permit maintenance of a constant angle ofpenetration of the RF needle electrode through a sphincter surface. 20.The apparatus of claim 17, wherein the retainer member has sufficientrigidity to reduce movement of the sphincter and facilitate introductionof the RF needle electrode into the sphincter.
 21. The apparatus ofclaim 1, wherein the retainer member at least partially surrounds theenergy delivery device introduction member to reduce a movement of theenergy delivery device introduction member within the sphincter.
 22. Theapparatus of claim 1, wherein the retainer member at least partiallysurrounds the energy delivery device introduction member and includes aslot to enhance an engagement of the energy delivery device introductionmember with the sphincter.
 23. The apparatus of claim 17, wherein theretainer member at least partially surrounds the energy delivery deviceintroduction member and includes a slot to enhance an engagement of theenergy delivery device introduction member with the sphincter andfacilitate introduction of the RF needle electrode into the sphincter.24. The apparatus of claim 17, wherein the retainer member at leastpartially surrounds the energy delivery device introduction member andincludes a slot to enhance an engagement of the energy delivery deviceintroduction member with the sphincter and reduce an amount of tearingof a sphincter mucosa upon an introduction of the RF needle electrodeinto the sphincter.
 25. The apparatus of claim 17, wherein the retainermember at least partially surrounds the energy delivery deviceintroduction member and includes a slot to enhance an engagement of theenergy delivery device introduction member with the sphincter and permitmaintenance of a constant angle of penetration of the RF needleelectrode through a sphincter surface.
 26. The apparatus of claim 9,wherein the balloon has a tapered tip to facilitate introduction into asphincter.
 27. The apparatus of claim 10, wherein the basket device hasa tapered tip to facilitate introduction into a sphincter.
 28. Theapparatus of claim 1, wherein the at least a portion of the energydelivery device introduction member is in a contacting relationship witha surface of the sphincter in the deployed configuration.
 29. Theapparatus of claim 28, wherein the energy delivery device introductionmember has a texturized surface with a sufficient coefficient offriction to reduce a movement of a sphincter surface.
 30. The apparatusof claim 28, wherein the energy delivery device introduction member hasa texturized surface with a sufficient coefficient of friction to reducea movement of an energy delivery device introduction member.
 31. Theapparatus of claim 28, wherein the energy delivery device introductionmember has a texturized surface with a sufficient coefficient offriction to reduce a movement of a sphincter surface and facilitateintroduction of the RF needle electrode into the sphincter.
 32. Theapparatus of claim 28, wherein the energy delivery device introductionmember has a texturized surface with a sufficient coefficient offriction to reduce a movement of a sphincter surface and reduce anamount of tearing of a sphincter mucosa upon an introduction of the RFneedle electrode into the sphincter.
 33. The apparatus of claim 28,wherein the energy delivery device introduction member has a texturizedsurface with a sufficient coefficient of friction to reduce a movementof a sphincter surface and permit maintenance of a constant angle ofpenetration of the RF needle electrode through a sphincter surface. 34.The apparatus of claim 17, wherein the energy delivery deviceintroduction member is a basket device and the RF electrode is coupledto an electrode delivery member having proximal and distal ends.
 35. Theapparatus of claim 34, further comprising: a guiding tool coupled to theelectrode delivery member, the guiding tool having at least one aperturewith a proximal end and a distal end, wherein the RF electrode isadvanced through the aperture in the guiding tool and the introductionof the RF needle electrode into the sphincter is facilitated.
 36. Theapparatus of 35 wherein the aperture proximal end and the aperturedistal end are located in a different plane.
 37. The apparatus of claim35, wherein the RF electrode is advanced through an aperture in theenergy delivery device introduction member.
 38. The apparatus of claim17, wherein the energy delivery device introduction member is a basketdevice and the RF electrode is coupled to an electrode delivery memberhaving proximal and distal ends.
 39. The apparatus of claim 38, furthercomprising: a guiding tool coupled to the energy delivery device, theguiding tool having at least one aperture with a proximal end and adistal end, wherein the RF electrode is advanced through the aperture inthe guiding tool and the introduction of the RF needle electrode intothe sphincter is facilitated.
 40. The apparatus of 39, wherein theaperture proximal end and the aperture distal end are located in adifferent plane.
 41. The apparatus of claim 39, wherein the RF electrodeis advancable through an aperture in the energy delivery deviceintroduction member.